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NCT Number: NCT05127720

Pacemaker-based Long-term Monitoring of Sleep Apnea

This is a prospective, non-interventional cohort study. It tests the hypothesis that

* Pacemaker-derived monitoring of sleep-related breathing disorders and/or daily physical activity predicts clinical outcome. * Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts clinical outcome in pacemaker patients. * Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts the occurrence of device-detected atrial fibrillation and/or device-detected sleep apnea. * Enviromental factors such as ambient temperature, humidity, precipitation, air pressure impacts device-detected atrial fibrillation and/or device-detected sleep apnea. * Variation of night-to-night device-detected sleep apnea shows sex-specific patterns and impacts device-detected atrial fibrillation burden, ventricular pacing rate in sick sinus syndrome and clinical outcomes. * Burden / variation of device-detected sleep apnea and/or device-detected atrial fibrillation correlates with the incidence and severity of common ophthalmologic diseases.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location status: Recruiting

About this study

All forms of arrhythmias, sleep apnea during sleeping hours and physical activity using sensors in modern implanted pacemakers as well as autonomic imbalance measures will be correlated with the incidence and progression (within 5 years of follow-up) of common co-morbidities such as arterial hypertension, coronary artery disease, heart failure, COPD, peripheral artery disease, iron insufficiency. In a long follow up perspective major adverse cardiovascular events will be recorded and new risk scores will be developed, incorporating machine learning techniques.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • implanted Microport TEO SR/DR or BOREA SR/DR or ALIZEA SR/DR pacemaker device
  • signed informed consent

Exclusion criteria

  • any contraindication to perform a cardiac CT examination
  • eGFR < 30 ml/min/1.73 m2
  • allergy against CT contrast medium
  • hyperthyreoism
  • inability of the patient to understand the study purpose and plan
  • inability of the patient to perform baseline examinations
  • pregnancy or breast-feeding; women with childbearing potential
  • estimated life expectancy below one year

Treatment and study plan

Primary outcomes

  1. 3P-MACE

    Time frame: time to first event, follow up for 120 months

    death, myocardial infarction and/or stroke

  2. device-detected atrial fibrillation

    Time frame: time to first event, follow up for 120 months

    first episode lasting more than 6 minutes or 24 hours

  3. device-detected atrial fibrillation

    Time frame: after 1, 3, 5 years

    total burden

  4. device-detected sleep apnea

    Time frame: after 1, 3, 5 years

    severity (RDI < versus > 20/h)

  5. device-detected sleep apnea

    Time frame: after 1, 3, 5 years

    variation

Secondary outcomes

  1. incidence of common opthalmological disease

    Time frame: assessed within the first year after study enrollment

    in correlation to device-detected sleep apnea and device-detected atrial fibrillation

  2. Deterioration of lung function

    Time frame: after 5 years

    conventional lung function testing

  3. Progression of subclinical peripheral artery disease

    Time frame: after 5 years

    sonography

  4. Progression of subclinical peripheral artery disease

    Time frame: after 5 years

    ABI

  5. QoL assessment

    Time frame: after 5 years

    EQ-5D-5L

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

Schrittmacher-basiertes Schlafapnoe Langzeit-Monitoring

Acronym: ACaSA

Important dates

Study start
2021
Primary completion
2041
Study completion
2041
First posted
Nov 19, 2021
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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